Why does SpectraCell’s Micronutrient Test not need FDA approval?
SpectraCell’s intracellular Micronutrient Test is a Lab Developed Test.
For highly specialized, complex, proprietary laboratory tests that are only performed by a single laboratory, FDA approval is neither appropriate nor required. FDA approval applies to lab tests that are extremely common, widely available from different labs or commodity type analytes, such as blood sugar testing or pregnancy tests, for example. That is why the FDA states that LDTs do not require FDA approval.
SpectraCell’s micronutrient test is called an LDT, or Laboratory Developed Test. FDA approval is not required nor feasible for LDTs because these are highly advanced and specialized diagnostic tests that are developed and performed within a specialized laboratory. To get FDA approval would take years of clinical trials, which is understandably not possible for specialized laboratories like SpectraCell.
What is an LDT?
Laboratory Developed Tests (LDTs) are defined as “in vitro diagnostic tests that are designed, manufactured and used within a single laboratory.” LDTs are often based on proprietary, even patented technology. Therefore, the FDA cannot compare LDTs among different laboratories. Many innovative and highly specialized lab tests are considered LDTs. Spectracell’s MicroNutrient Test (MNT) is a classic example of an LDT.
According to the FDA, thousands of LDTs exist in over 600 labs, which suggests that requiring FDA approval for LTDs would likely stifle innovation in the lab industry. This further supports the notion that requirements for highly specialized advanced diagnostics should differ significantly in from commodity lab tests that are performed by national labs. As stated by the FDA on their website:
“While the uses of an LDT are often the same as the uses of FDA- cleared or approved in vitro diagnostic tests, some labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D on the market”
What governing body has authority over SpectraCell?
SpectraCell is a CLIA-accredited laboratory. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are the federal regulations that apply to all clinical laboratories operating within the United States that performed testing on human samples. In order to maintain certification, SpectraCell has to undergo routine CLIA inspections and maintain documentation on all quality control procedures. CLIA certification assures validity and reliability of SpectraCell’s Micronutrient Test procedures and results.
Source: Food and Drug Administration Notification and Medical Device Reporting for Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories. Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notice.